1、May 2014Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.0
2、40.10; 11.040.25; 11.060.20!%1,“2149409www.din.deDDIN ISO 11040-3Prefilled syringes Part 3: Seals for dental local anaesthetic cartridges (ISO 11040-3:2012),English translation of DIN ISO 11040-3:2014-05Vorgefllte Spritzen Teil 3: Dichtungen fr Dentalkarpulen zur Lokalansthesie (ISO 11040-3:2012),En
3、glische bersetzung von DIN ISO 11040-3:2014-05Seringues prremplies Partie 3: Rondelles dtanchit pour cartouches dentaires danesthsie locale(ISO 11040-3:2012),Traduction anglaise de DIN ISO 11040-3:2014-05SupersedesDIN ISO 11040-3:1993-11www.beuth.deIn case of doubt, the German-language original shal
4、l be considered authoritative.Document comprises 11 pages04.14 DIN ISO 11040-3:2014-052A comma is used as the decimal marker. National foreword This document (ISO 11040-3:2012) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for
5、 medical and pharmaceutical use” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-15 AA Elastomere Pharmapackmittel und zugehrige Komponenten. Attention is drawn to the poss
6、ibility that some of the elements of this document may be the subject of patent rights. DIN and/or DKE shall not be held responsible for identifying any or all such patent rights. It should be noted that this standard includes a National footnote to explain an abbreviation in the English reference v
7、ersion. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 48 DIN ISO 48 ISO 3302-1 DIN ISO 3302-1 ISO 3302-2 DIN ISO 3302-2 ISO 7405 DIN EN ISO 7405 ISO 7619-1 DIN ISO 7619-1 ISO 7885 DIN EN ISO 7885 ISO 8871-1 DIN EN ISO 8871-1 ISO 8871-
8、4 DIN EN ISO 8871-4 ISO 8871-5 DIN ISO 8871-5 ISO 8872 DIN EN ISO 8872 ISO 9997 DIN EN ISO 9997 ISO 10993-1 DIN EN ISO 10993-1 ISO 11040-1 DIN ISO 11040-1 ISO 11040-2 DIN ISO 11040-2 ISO 11499 DIN EN ISO 11499 ISO 13926-2 DIN ISO 13926-2 ISO 15378 DIN EN ISO 15378 DIN ISO 11040 consists of the follo
9、wing parts, under the general title Prefilled syringes: Part 1: Glass cylinders for dental local anaesthetic cartridges Part 2: Plunger stoppers for dental local anaesthetic cartridges Part 3: Seals for dental local anaesthetic cartridges Part 4: Glass barrels for injectables Part 5: Plunger stopper
10、s for injectables Part 6: Plastics barrels for injectables DIN ISO 11040-3:2014-053The following part is under preparation: Part 7: Packaging systems for prefillable ready-to-use syringes Amendments This standard differs from DIN ISO 11040-3:1993-11 as follows: a) the scope has been extended to be i
11、n line with the new edition of DIN ISO 11040-2; b) a classification of seals has been included; c) the designation has been changed; d) dimensional requirements have been revised; e) material requirements have been revised; f) physical requirements and test methods have been revised; g) for chemical
12、 and biological requirements reference is made to ISO 8871-1 and ISO 8871-4; h) the former Clause 7 (now Clause 8) “Labelling” has been revised; i) the former Clause 6 “Packaging” has been deleted; j) Annex A “Leakage test” has been added; k) the standard has been editorially revised. Previous editi
13、ons DIN 58358-3: 1986-07 DIN ISO 11040-3: 1993-11 National Annex NA(informative)Bibliography DIN EN ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used in dentistry DIN EN ISO 7885, Dentistry Sterile injection needles for single use DIN EN ISO 8871-1, Elastomeric parts for par
14、enterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN EN ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods DIN EN ISO 8872, Aluminium caps for transfusion, infusion and inje
15、ction bottles General requirements and test methods DIN EN ISO 9997, Dental cartridge syringes DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 11499, Dentistry Single-use cartridges for local anaesthetics DIN EN I
16、SO 15378, Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) DIN ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) DIN ISO 330
17、2-1, Rubber Tolerances for products Part 1: Dimensional tolerances DIN ISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerances DIN ISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) DIN EN ISO 8871-5, Elas
18、tomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testing DIN ISO 11040-1, Prefilled syringes Part 1: Glass cylinders for dental local anaesthetic cartridges DIN ISO 11040-2, Prefilled syringes Part 2: Plunger stoppers for dental local anaesthet
19、ic cartridges DIN ISO 13926-2, Pen systems Part 2: Plunger stoppers for pen-injectors for medical use DIN ISO 11040-3:2014-054Introduction Primary packaging components made of elastomeric materials are an integral part of medicinal products. Therefore, the principles of current good manufacturing pr
20、actices (cGMPN1) apply to the manufacturing of these components. Principles of cGMP are described in ISO 15378 or in the GMP Guidelines published by the European Community and the United States of America. N1) National footnote: cGMP, de: aktuelle Regeln der Guten Herstellungspraxis DIN ISO 11040-3:
21、2014-0551 ScopeThis part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and stora
22、ge can be significantly affected by the nature and performance of the primary packaging.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of
23、 the referenced document (including any amendments) applies.ISO 3302-1, Rubber Tolerances for products Part 1: Dimensional tolerancesISO 7619-1, Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)ISO 7885:2010, Dentistry Sterile dental
24、injection needles for single useISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavatesISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methodsISO 88
25、71-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 5: Functional requirements and testingISO 8872, Aluminium caps for transfusion, infusion and injection bottles General requirements and test methodsISO 11040-1, Prefilled syringes Part 1: Glass cylinders for den
26、tal local anaesthetic cartridgesISO 11040-2, Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges3 ClassificationSeals shall be classified as follows: type A: seals with a mono-layer disc; type B: seals with a double-layer disc.4 Shape and dimensions4.1 The shape and d
27、imensions of seals shall be as shown in Figure 1 and given in Table 1.Prefilled syringes Part 3: Seals for dental local anaesthetic cartridges DIN ISO 11040-3:2014-056Dimensions in millimetresType A: Seal with a mono-layer discType B: Seal with a double-layer discShape and dimensions of seals for de
28、ntal local anaesthetic cartridgesDimensions of sealsDimensions in millimetresNominal size Type Total cap heightaThickness of discInner cap diameterBore diameterh1h2d1d20,15 0,15 0,05 0,37,5 A 4,85 to 4,9 1,3 to 1,5 7,5 3,07,5 B 4,85 to 5,3 1,45 to 1,95 7,5 3,0aThe height of the seal depends on the t
29、hickness and hardness of the disc.4.2 For type B seals, both single layers shall be continuous. The thickness ratio of the single layers shall be agreed upon between the supplier and user.4.3 The diameter of the rubber discs shall be such that a sufficient press-fit in the aluminium cap is achieved
30、and that the discs cannot fall out.4.4 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1.DIN ISO 11040-3:2014-0575 DesignationSeals are designated according to their type (see Clause 3 and Figure 1). The designation shall comprise, in the following ord
31、er, the descriptor “Seal”, a reference to this part of ISO 11040 and the type letter.EXAMPLE Designation of a seal of type A (i.e. trimmed):Seal ISO 11040-3 - A6 Material6.1 CapGeneral requirements for aluminium caps shall be in accordance with ISO 8872. In addition, the cap shall be anodized or sui
32、tably lacquered.6.2 DiscsDiscs shall be made from the elastomeric formulation originally tested and approved by the end user. The manufacturer of the discs shall ensure the conformance of each delivery with the type sample and the compliance with previously agreed functional and compendial requireme
33、nts.The elastomeric material shall withstand two sterilization cycles when autoclaving in saturated steam at (121 2) C for 30 min without impairment of its function under conditions of normal use. If other sterilization methods are used, e.g. irradiation, the suitability of the material shall be eva
34、luated.7 Requirements7.1 GeneralThe requirements specified in 7.2 to 7.4 constitute minimum requirements concerning the condition of the elastomeric seals on receipt by the user.7.2 Physical requirements7.2.1 Hardness of the discThe hardness agreed between the manufacturer and the user shall not dif
35、fer from the nominal value by more than 5 Shore A when tested in accordance with ISO 7619-1 on a special test specimen. Alternatively, hardness can be tested on the discs in accordance with ISO 48. If tested according to ISO 48, the microhardness shall not differ by more than 5 IRHD from the type sa
36、mple.The manufacturer should provide suitable test specimens upon request.7.2.2 FragmentationThe requirements and test method of ISO 8871-5:2005, 4.2 and Annex B, shall apply, using a needle with an outer diameter of 0,4 mm that conforms to the butt-end requirements in ISO 7885:2010, 5.3.Schematic r
37、epresentation of butt-end angleDIN ISO 11040-3:2014-0587.2.3 Freedom from leakageThe seal of the cartridge shall show no signs of leakage when tested in accordance with Annex A.7.2.4 Resistance to ageingThe maximum time between the date of manufacture of the seals and their pharmaceutical use should
38、 be agreed upon between the manufacturer and the user.The seals shall maintain their performance characteristics throughout the entire shelf-life of the medicinal product, which is tested as part of the stability test by the user.NOTE Ageing depends on storage and handling conditions. A guide to sto
39、rage of vulcanized rubber is given in ISO 2230.7.3 Chemical requirementsThe requirements of ISO 8871-1 shall apply for the disc.7.4 Biological requirementsThe requirements of ISO 8871-4 shall apply.Toxicity tests apply to the disc only.8 LabellingPacked seals that meet the requirements of this part
40、of ISO 11040 can be labelled with the designation given in Clause 5.DIN ISO 11040-3:2014-059Annex A (normative) Leakage testA.1 PrincipleWater-filled cartridges are prepared using the seals to be tested. By means of a suitable device, a force is applied to the seal during a defined time interval. An
41、y observed leakage is recorded.The leakage tests for seals and plunger stoppers (see ISO 11040-2) can be combined.A.2 ApparatusA.2.1 Cartridge cylinders, in accordance with ISO 11040-1.A.2.2 Seals to be tested.A.2.3 Plunger stoppers, in accordance with ISO 11040-2.A.2.4 Suitable equipment, to prepar
42、e water-filled cartridges.A.2.5 Cartridge holder, e.g. as specified in ISO 9997 or ISO 11499.A.2.6 Pressurizing device, capable of applying a force of (30 1) N.A.3 ProcedureA.3.1 Take 10 cartridges and fill them with water until they are practically air-free using the seals to be tested.NOTE The wat
43、er may be replaced by a coloured solution in order to improve the visibility of the leakage.A.3.2 Place the first cartridge, mounted in the cartridge holder (A.2.5), into the pressurizing device (A.2.6), and apply a force of (30 1) N for 1 min. Check for leakage at the seal.SAFETY PRECAUTIONS Adequa
44、te safety measures should be in place to protect the operator.A.3.3 Repeat the operation described in A.3.2 on the remaining cartridges.A.4 Expression of resultsReport the number of leakages observed at the seal.Report whether the testing of the seals and plunger stoppers (see ISO 11040-2) has been
45、combined.DIN ISO 11040-3:2014-0510Bibliography1 ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)2 ISO 2230, Rubber products Guidelines for storage3 ISO 3302-2, Rubber Tolerances for products Part 2: Geometrical tolerances4 ISO 7405, Dentis
46、try Evaluation of biocompatibility of medical devices used in dentistry5 ISO 9997, Dental cartridge syringes6 ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process7 ISO 11499, Dentistry Single-use cartridges for local anaesthetics8 ISO 13926-2, Pen systems Part 2: Plunger stoppers for pen-injectors for medical use9 ISO 15378, Primary packaging materials for medicinal products Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)DIN ISO 11040-3:2014-0511
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